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Tolerability of HIV postexposure prophylaxis with tenofovir/emtricitabine and lopinavir/ritonavir tablet formulation

Tosini, Williama,b; Muller, Philippec; Prazuck, Thierryd; Benabdelmoumen, Ghaniab; Peyrouse, Erice; Christian, Bernardc; Quertainmont, Yannf; Bouvet, Elisabetha,b; Rabaud, Christiana,c

doi: 10.1097/QAD.0b013e32833dfad1
Clinical Science

Objective: To evaluate the tolerability of HIV postexposure prophylaxis (PEP) with tenofovir/emtricitabine and lopinavir/ritonavir tablet formulation (TDF/FTC+LPV/r).

Design: Multicentric observational prospective study.

Method: Adults with an HIV transmission risk in the past 48 h were eligible. Baseline sociodemographic characteristics, description of exposure event, and HIV serostatus of the source patient were collected. Laboratory monitoring for toxicity and a clinical evaluation were performed; adherence and side effects were recorded using a standardized form on day 0, 15, and 28.

Results: Between November 2006 and June 2008, 249 participants were included in 10 French hospitals. Mean age was 31.5 ± 10 years. Sex ratio male/female was 1.96. Exposure events are as follows: occupational exposure, 40 (16%); sexual intercourse, 204 (82%); and other, 5 (2%). Tolerability could be evaluated in 188 cases. In 22 cases, PEP was discontinued for adverse effects before day 28, including two cases of skin rash related to TDF/FTC prescription, one renal lithiasis related to LPV/r prescription, and one rhabdomyolysis. One hundred and sixty-six persons completed the 28 days of PEP with tolerability judged as good in 96 (58%) individuals. Among everyone who experienced at least one side effect, 78% reported diarrhea, 78% asthenia, and 59% nausea and/or vomiting.

Conclusion: Considering data of previous studies performed using similar methodology, the dropout rate due to adverse events appeared significantly lower in TDF/FTC+LPV/r tablet formulation than those in zidovudine/lamivudine (ZDV/3TC)+nelfinavir (P < 0.0001), ZDV/3TC+lopinavir/ritonavir soft gel capsules (P < 0.01), and 3TC+TDF+atazanavir boosted by ritonavir (P < 0.05) and should be considered as standard of care concerning HIV PEP.

aGroupe d'Etude sur le Risque d'exposition des Soignants aux Agents Infectieux (GERES), France

bHôpital Bichat Claude-Bernard, Paris, France

cCOREVIH Lorraine Champagne Ardenne, Centre Hospitalier et Universitaire, Nancy, France

dCentre Hospitalier Régional, Orléans, France

eHôpital Sainte Marguerite, Marseille, France

fHôpital Bicêtre, Paris, France.

Received 8 September, 2009

Revised 1 July, 2010

Accepted 6 July, 2010

Correspondence to Dr William Tosini, GERES, Université Paris Diderot Paris 7, UFR de Médecine site Bichat, 16 rue Henri Huchard, 75890 Paris Cedex 18, France. E-mail:

© 2010 Lippincott Williams & Wilkins, Inc.